Fosfen Forte Xforte Essential Phospholipids with Vitamin Capsules

FOSFEN FORTE®/ FOSFEN XFORTE®

(Essential Phospholipids with Vitamin Capsules)

 

Description

FOSFEN FORTE

Opaque brown coloured oval shaped soft gelatin capsules contains brown colour oily mass.

 

FOSFEN XFORTE

Opaque brown coloured oblong shaped soft gelatin capsules contains brown colour oily mass.

 

Composition

FOSFEN FORTE

Each Soft gelatin Capsule contains:

Lecithin USP

Containing Essential Phospholipids 300.0 mg

Thiamine Nitrate BP 10.0 mg

Riboflavin BP 6.0mg

Pyridoxine Hydrochloride BP 10.0 mg

Cyanocobalamin (1% Triturate) 10.0 mcg

Vitamin E (dl-aphaI Tocopheryl Acetate) USP 10.0 mg

Nicotinamide BP 30.0 mg

Folic Acid BP 1.0 mg

Excipients q.s.

 

FOSFEN XFORTE

Each Soft gelatin Capsule contains:

Lecithin USP

Containing Essential Phospholipids 500.0 mg

Thiamine Nitrate BP 10.0 mg

Riboflavin BP 6.0 mg

Pyridoxine Hydrochloride BP 10.0 mg

Cyanocobalamin (1% Triturate) 10.0 mcg

Vitamin E (dl-alpha Tocopheryl Acetate) USP 10.0 mg

Nicotinamide BP 30.0 mg

Folic Acid BP 1.0mg

Excipients q.s.

 

Pharmacological Action

Pharmacokinetics

Essential phospholipids

In studies of pharmacokinetics in humans of less than 5% of each of the isotopes introduced H3 and C14 excreted in faeces.

 

Vitamin B1 (Thiamine)

Thiamine is absorbed from the gastro-intestinal tract and is widely distributed to most body tissues. Amounts in excess of the body’s requirements are not stored but excreted in the urine as unchanged thiamine or its metabolites.

 

Vitamin B2 (Riboflavin)

Riboflavin is absorbed from the gastro-intestinal tract and in the circulation is bound to plasma proteins. It is widely distributed. Little is stored and excess amounts re excreted in the urine.

In the body Riboflavin is converted to flavin mononucleotide (FMN) and then to flavin adenine dinucleotide (FAD).

 

Vitamin B6 (Pyridoxine)

Pyridoxine is absorbed from the gastro-intestinal tract and converted to the active pyridoxal phosphate which is bound to plasma proteins. It is excreted in the urine as 4 pyridoxic acid.

 

Vitamin B12 (Cyanocobalamin)

Cyanocobalamin is absorbed from the gastro-intestinal tract and is extensively bound to specific plasma proteins. A study with labelled Vitamin B12 showed it was quickly taken up by the intestinal mucosa and held there for 2 – 3 hours. Peak concentrations in the blood and tissues did not occur until 8 – 12 hours after dosage with maximum concentrations in the liver within 24 hours. Cobalamins are stored in the liver, excreted in the bile and undergo enterohepatic recycling. Part of a dose is excreted in the urine, most of it in the first eight hours.

 

Vitamin E

Vitamin E is absorbed from the gastro-intestinal tract. Most appears in the lymph and is then widely distributed to all tissues. Most of a dose is slowly excreted in the bile and the remainder is eliminated in the urine as glucuronides of tocopheronic acid or other metabolites.

 

Folic Acid

Folic acid is absorbed mainly from the proximal part of the small intestine. Folate polyglutamates are considered to be deconjugated to monoglutamates during absorption. Folic acid rapidly appears in the blood where it is extensively bound to plasma proteins. Some folic acid is distributed in body tissues, some is excreted as folate in the urine and some is stored in the liver as folate.

 

Pharmacodynamics

Essential phospholipids

Essential phospholipids normalize liver function and enzymatic activity of liver cells, decrease the level of energy consumption by the liver, promote regeneration of liver cells, convert the neutral fats and cholesterol in the compounds facilitating their metabolism, stabilize the physical and chemical properties of bile. Essentiale normalizes protein metabolism and improves detoxication liver function, inhibit the formation of connective tissue in the liver.

 

Vitamin B1 (Thiamine)

Thiamine (as the coenzyme, thiamine pyrophosphate) is associated with carbohydrate metabolism. Thiamine pyrophosphate also acts as a co enzyme in the direct oxidative pathway of glucose metabolism. In thiamine deficiency, pyruvic and lactic acids accumulate in the tissues. The pyruvate ion is involved in the biosynthesis of acetylcholine via its conversion to acetyl co-enzyme A through a thiamine-dependent process. In thiamine deficiency, therefore, there are effects on the central nervous system due either to the effect on acetylcholine synthesis or to the lactate and pyruvate accumulation. Deficiency of thiamine results in fatigue, anorexia, gastro-intestinal disturbances, tachycardia, irritability and neurological symptoms. Gross deficiency of thiamine (and other Vitamin B group factors) leads to the condition beri-beri.

 

Vitamin B2 (Riboflavin)

Riboflavin is phosphorylated to flavin mononucleotide and flavin adenine dinucleotide which act as co-enzymes in the respiratory chain and in oxidative phosphorylation.

Riboflavin deficiency presents with ocular symptoms, as well as lesions on the lips and at angles of the mouth.

 

Vitamin B6 (Pyridoxine)

Pyridoxine, once absorbed, is rapidly converted to the co-enzymes pyridoxal phosphate and pyridoxamine phosphate which play an essential role in protein metabolism.

Convulsions and hypochromic anaemia have occurred in infants deficient in pyridoxine.

 

Vitamin B12 (Cyanocobalamin)

Vitamin B12 is present in the body mainly as methylcobalamin and as adenosylcobalamin and hydroxocobalamin. These act as co-enzymes in the trans methylation of homocysteine to methionine; in the isomerisation of methylmalonyl co enzyme to succinyl co-enzyme and with folate in several metabolic pathways respectively. Deficiency of Vitamin B12 interferes with haemopoiesis and produces megaloblastic anaemia.

 

Vitamin E

Vitamin E deficiency has been linked to disorders such as cystic fibrosis where fat absorption is impaired, it is essential for the normal function of the muscular system and the blood.

 

Folic Acid

Folic acid is reduced in the body to tetrahydrofolate which is a co-enzyme for various metabolic processes, including the synthesis of purine and pyrimidine nucleotides and hence in the synthesis of DNA. It is also involved in some amino acid conversion and in the formation and utilisation of formate. Deficiency of folic acid leads to megaloblastic anaemia.

 

Indication

As nutritional support in the management of treatment of fatty degeneration of the liver, hepatitis (including toxic hepatitis, liver damage caused by medicines or alcohol abuse), cirrhosis of the liver, disturbances in liver function associate with different illnesses.
Nutritional support in the management of damaged liver (due to chronic disease, liver cirrhosis, fatty liver and intoxication by hepatotoxic substances).

 

Dosage and Administration

1-2 Capsules 3 times a day with meals. On medical advice, the dose may be increased.

Capsules are to be swallowed whole with a little liquid if desired.

 

Contra-Indication

Essential Phospholipids

Do not use Essential Phospholipids in hypersensitivity or allergy to any ingredients of the preparation.

 

Vitamin B Complex

Diverticular Disease, Ulcer from Stomach Acid, Ulcerated Colon, Inflammation of the Lining of the Stomach and Intestines.

 

Vitamin E

Vitamin E may be contraindicated in bleeding disorders.

 

Warnings and Precaution

Essential Phospholipids

The application of Essential Phospholipids in newborn children is not safe. During pregnancy women are recommended to consult their health care provider prior to taking Essential Phospholipids.

 

Vitamin B Complex

Before you decide to take a Vitamin B Complex, talk to your doctor to determine whether it is right for you. Always let your doctor know if you are taking other medications, including those over the counter, or other vitamins. Make it clear if you suffer from gout, diabetes, liver problems, stomach ulcers or drug allergies. Finally, if you are pregnant or breastfeeding, always consult a doctor to determine whether Vitamin B complex is safe for you and your baby.

 

Vitamin E

Tell your doctor your medical history, especially of: allergies (including sulfa drugs), diabetes, high blood cholesterol or fats (lipids), liver or kidney disorders, blood disorders (hemophilia), digestive disorders (malabsorption). Caution is advised when this drug is used in the elderly as this group may be more prone to drug side effects. This medication should be used only when clearly needed during pregnancy. Discuss the risks and benefits with your doctor. It is not known whether this drug passes into breast milk.

Avoid breast-feeding because breast milk can transmit HIV. Consult your doctor or pharmacist for more information.

 

Side Effects

Essential Phospholipids

In very rare cases it can cause: abdominal pain, nausea, diarrhea and allergic reaction (skin rash). In studies, reported side effects of Essential Phospholipids included: Nausea, Diarrhea Abdominal pain or fullness. Essential Phospholipids is derived from either egg or soy. Therefore, people with egg or soy allergies may develop allergic reactions to Essential Phospholipids. Seek immediate medication attention if you develop signs of an allergic reaction, such as: A rash or hives, Itching, Swelling of the lips, mouth, or throat, Wheezing or difficulty breathing.

 

Vitamin B Complex

Side effects of taking a B vitamin complex are not common, especially if the patient takes the medication as prescribed amount. Taking excessive amounts of a vitamin B complex can cause side effects. An overdose is signaled by: dizziness, frequent urination, change in the color of the urine, black stools, constipation, diarrhea, abdominal pain, nausea, vomiting, redness of the skin and itching.

 

Vitamin E

Overdoses (>1g) have been associated with minor side effects, including hypertension, fatigue, diarrhea and myopathy.

 

Adverse reaction

Essential Phospholipids

In studies, reported side effect of Essential phospholipids capsules included: Nausea, Diarrhea, Abdominal pain or fullness. People allergic with Soya or egg may develop allergic reaction with Essential phospholipids capsules because essential phospholipids are derived from either egg or Soya. Seek immediate medication attention if you develop signs of an allergic reaction, such as a rash or hives, itching, swelling of the lips, mouth, or throat, wheezing or difficulty in breathing.

Occasionally, the administration of Essential phospholipids capsules may provoke gastrointestinal disorders e.g. Stomach complaints soft stool, and diarrhea.

In very rare occasion it may cause, abdominal pain, nausea, and allergic reaction e.g. exanthema and urticaria. The doctor or pharmacist should be informed about any undesirable effect not previously mentioned.

Administration of Essential phospholipids capsules should be discontinued in the events of any one above mentioned side effects, especially if hypersensitivity reaction occurs. The patients should consult the doctor to decide about the severity and any measures that might be necessary.

 

Vitamin E

Eating vitamin E in foods is not risky or harmful. In supplement form, however, high doses of vitamin E might increase the risk for bleeding and serious bleeding in the brain. High levels of vitamin E may also increase the risk of birth defects.

 

Drug Interaction

Essential Phospholipids

Before taking Essential Phospholipids tell your doctor if you are taking any other prescription or over-the-counter medicines.

 

Vitamin B Complex

Each type of B vitamin interacts differently with certain types of medications. However, all B vitamins interact similarly with tetracycline, an antibiotic. B vitamins prevent the absorption of tetracycline and interferes with its activity. You should never take B vitamins concurrently with tetracycline. Consult with your health care provider before taking any vitamin supplements if you are also taking other medications.

 

Vitamin E

Vitamin E may impair the absorption of Vitamin A.

Vitamin K functions impairment happens at the level of prothrombin formation and potentiates the effect of Warfarin.

 

Over dosage

Essential Phospholipids

Seek emergency medical attention most commonly, symptoms of an Essential Phospholipids overdose include nausea and vomiting.

 

Vitamin B complex

Vitamin B complex overdose is a factor that you should always watch out for, and the best way to do that is to consume it only in the recommended form. The side effects vary as per overdose of each of the component of these 8 vitamins. Some of the common vitamin B side effects include, diarrhea, abdominal cramps, bloating and other problems related to digestive health, insomnia, eye problems, bitter taste in mouth, calcium deficiency, hyperactivity, increased severity of certain mental conditions like depression and irritability, reduced metabolism rate and nutrition absorption. Some other side effects include anemia, low blood pressure, headache, heart palpitation, edema, joint pain, itching and flushing of skin, mood swings, loss of appetite, etc.

 

Vitamin E

Symptoms of overdose may include nausea, weakness, intestinal cramps, headache, flatulence, diarrhea, drowsiness, or loss of consciousness.

 

Storage

Store below 30°C at dry place. Protect from light.

 

Presentation

FOSFEN FORTE/ FOSFEN XFORTE is presented in blister packs of 3 x10 box.

®- Registered Trade Mark

 

Manufactured by

SOFTGEL HEALTHCARE PVT LIMITED

Survey No. 20/1, Vandalur- Kelambakkam Road,

Pudupakkam Village, Kancheepuram District,

Tamilnadu – 603 103, India.

 

Manufactured for

BIOMEDICINE S.P.N.L.

No 16 Anionwu Street Odoakpu

Onitsha, Nigeria.

Sckivspharm@yahoo.com

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